Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008697
Company: PHARMACIA AND UPJOHN

Products on NDA 8697

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CORTEF	HYDROCORTISONE	10MG	TABLET;ORAL	Prescription	AB	Yes	No
CORTEF	HYDROCORTISONE	20MG	TABLET;ORAL	Prescription	AB	Yes	Yes
CORTEF	HYDROCORTISONE	5MG	TABLET;ORAL	Prescription	AB	Yes	No

Labels for NDA 008697

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/05/2024	SUPPL-40	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/008697s040lbl.pdf
12/20/2023	SUPPL-38	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/008697s038lbl.pdf
11/21/2019	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/008697s036lbl.pdf
09/08/2016	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008697s032_33lbl.pdf
09/08/2016	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008697s032_33lbl.pdf
12/28/1993	SUPPL-21	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/008697s021lbl.pdf